Diet-related diseases are among the leading causes of death globally(Reference Vos, Abajobir and Abate1). These global nutrition challenges are on the world policy stage. The Second International Conference on Nutrition, an inter-governmental meeting on nutrition jointly organized by the FAO and the WHO, took place in November 2014. As was discussed at the Conference, addressing these issues requires intersectoral action(2). In 2015, the 2030 Agenda for Sustainable Development launched seventeen Sustainable Development Goals. Goal 2 aims explicitly to end hunger and all forms of malnutrition by 2030. The political desire and urgency for action on global nutrition was highlighted when the UN General Assembly in April 2016 agreed on a resolution proclaiming the UN Decade of Action on Nutrition from 2016 to 2025. This provides an umbrella framework for UN agencies, governments and other key actors to exercise their role and responsibility for addressing malnutrition in all its forms. WHO and FAO are the lead UN agencies tasked with stewarding the implementation of the Decade of Action work programme across the UN system and in Member States via national health ministries.
Core to the Decade of Action on Nutrition is recognition that trade and investment agreements affect nutrition and that ‘coherence between trade and nutrition policies is vital’(3). Policy coherence can be defined as ‘a process through which governments make efforts to design policies that take account of the interests of other policy communities, minimize conflicts, maximize synergies and avoid unintended incoherence’(Reference Blouin4). Negative impacts of trade and investment agreements on nutrition (see Thow et al.(Reference Thow, Snowdon and Labonte5) and Schram et al.(Reference Schram, Ruckert and VanDuzer6) for comprehensive reviews of nutrition risks from trade) are arguably the consequences of trade policies developed without consideration of health sectoral policy goals, i.e. a classic example of policy incoherence. A challenge, therefore, for WHO, FAO, health ministries and other health-concerned organizations is how to ensure that trade agreements are developed in such a way that they support the objectives of improving nutrition, enable the implementation of nutrition policies and programmes, and do not negatively impact the right to adequate nutritious food.
To be able to engage with trade and investment for improved nutrition, health stakeholders must understand both the technical and the political dimensions of the issues. Understanding the technical dimensions of trade and nutrition, and in particular the ways in which trade agreements impact on nutritional outcomes, shines a light on the potential entry points for health policy intervention. It is this issue on which much of the evidence related to trade and nutrition has tended to focus, highlighting the technicalities of nutrition risks embedded within specific agreements and identifying options for more nutrition-sensitive rules or use of specific health exceptions or exclusions to the rules. In summary, market liberalization provisions in trade agreements tend to favour trade and investment in highly processed, energy-dense, nutrient-poor food products, which make excellent global commodities given their transportability, long shelf-lives, high profit margins, and suitability to global marketing and advertising. At the same time, regulatory provisions in trade and investment agreements increasingly extend ‘behind-the-border’, encroaching upon the ability of governments to introduce domestic policies that will address the negative externalities of trade-related changing food environments and reduce diet-related disease risks within nation states(Reference Thow, Snowdon and Labonte5–Reference Baker, Friel and Schram11). Figure 1 provides an overview of these interconnections between trade and diet-related disease risks and potential points of policy incoherence.
Fig. 1 Pathways from trade to diet-related disease risks; solid lines indicate trade policy instruments and dashed lines indicate different types of effects from the policy instrument (NCD, non-communicable disease)
Enabling coherence between trade and nutrition goals is, however, not a straightforward technical issue. It is highly political, involving many interest groups who often share competing interests, beliefs and worldviews. Health actors must therefore also understand the realpolitik of trade negotiations, with people, power and profits firmly at the centre of trade deliberations. As noted in the Decade of Action on Nutrition, ‘the rules governing trade and investment have become increasingly important to food systems’(3). Key questions are who sets the trade rules and how, and how can nutrition be brought into those rules? These are questions of governance and the focus of the present paper. By governance we mean the different actors (state and non-state, public and private) and the processes and structures that manage their interactions.
Trade decision-making processes involve interaction within and among state, civil society and private actors, in the context of a mix of economic, social and health priorities, and against a backdrop of prevailing social norms and values(Reference Kickbusch12,Reference Drope and Lencucha13) . As the issue of trade and investment and nutrition highlights, the needed policy actions fall outside health portfolios, requiring coordinated actions across many sectors, at multiple levels, within and outside government. Fundamentally, this raises issues of power – government priorities and decisions being shaped by the values and interests of powerful policy actors, the ideas they use to portray issues, the extent to which such portrayals resonate with existing ideologies and the strategies they adopt to advance their interests. A growing body of literature has started to address these political economy questions. Analyses have highlighted a lack of discursive power among health-related actors alongside the dominant market-based framing by industry(Reference Friel, Ponnamperuma and Schram14,Reference Townsend, Schram and Baum15) ; powerful corporate influence in recently negotiated trade agreements such as the Trans Pacific Partnership Agreement(Reference Ranald16); and privileging of export interest over health by governments(Reference Battams and Townsend17).
Based on what we know about health actors’ lack of discursive power, greater corporate access to the negotiating table, and power imbalances between trade and health sectors, we focus in the present paper on the governance processes available for policy actors to influence trade agreements. Our analysis responds to the 2014 Lancet Commission on Global Governance for Health’s recognition that ‘what merits increased attention, is a broader consideration of the many actors and forces outside the global health system and the ways in which they influence health’(Reference Ottersen, Dasgupta and Blouin18). Using data from interviews with Australian key informants in trade and health, we explore the factors that enable or constrain the consideration of the sorts of nutrition issues identified in Fig. 1 in the development of trade agreements. We highlight how the many actors involved in the development of trade agreements, including public servants, public-interest non-government agencies and business groups, pursue their differing and sometimes conflicting institutional interests and goals. In particular, we uncover the formal and informal mechanisms and structures inside and outside the trade negotiations, mapping out ways public health and nutrition actors engage with these mechanisms and structures. This knowledge will better inform health policy makers and advocates of the political dynamics within the trade policy-making arena, subsequently supporting the development of strategies that enhance their ability to guide trade agreements that are coherent with health policy (nutrition) goals.
Methods
This research adopted a qualitative study design and used key informant interviewing, a standard data-collection technique used in policy studies. Key informants were identified using a purposive snowball sampling strategy. Of the thirty individuals invited to participate in the study, nineteen accepted and eleven declined or did not respond. Semi-structured interviews were conducted by P.B. between March and May 2016 with informants from: the Australian government; peak body organizations representing the business sectors; public-interest non-government organizations (NGO); and academics. Each informant was an expert in the Australian trade policy environment and knowledgeable about the wider global and regional trading landscape. Academic informants were experts in trade and public health. Industry informants included representatives of peak body organizations representing the agricultural, grocery and general business sectors. Government informants spanned a number of relevant policy sectors including foreign affairs and trade, international law, food standards and health. Informants from NGO included a peak consumer body, a food sovereignty organization, a Fair Trade body and a peak public health organization. Table 1 provides an overview of the key informants’ characteristics. Six interviews were conducted by telephone and the remainder in-person. Interviews lasted between 40 and 75 min. One government representative declined to have the interview recorded and written notes were taken instead. All other interviews were recorded and transcribed verbatim.
Table 1 Characteristics of participants in key informant interviews, Australia, March–May 2016
NGO, non-governmental organization.
The interviews were guided by a series of questions organized by categories that enable understanding of the governance of policy issues and institutions(Reference Cairney19–Reference Clapp and Fuchs21): actors, ideas, formal and informal mechanisms and structures. Specifically, we investigated formal mechanisms (e.g. rules, committees), informal structures and processes, and institutional norms (e.g. primacy of economic growth v. social goals) that actors use to navigate and influence trade agreement decision-making processes. We explored the different actors and their agency to pursue their interests through the lens of power: ideational (i.e. the power of ideas and frames deployed by actors), instrumental (i.e. the power to directly influence decision makers through, for example, participation in networks/coalitions) and structural (i.e. the power to shape norms, rules and institutional arrangements).
Interviews were professionally transcribed and coded initially by P.B. using Atlas.ti software. A coding schema was developed using the theoretical constructs discussed above and additional emergent themes were captured using open coding. It is from this analytical approach that the results presented in Table 2 emerged. Internal validation of the themes was made by authors whereby author each read several transcripts and crossed-checked their themes with those identified by P.B. The final interpretation of the themes was clarified through discussion among all authors.
Table 2 Overview of key mechanisms and structures in governance of trade for nutrition goals
Codex, Codex Alimentarius; FCTF, Framework Convention for Tobacco Control; MP, Member of Parliament.
Inside is broadly defined as any government-initiated activity that is related to the negotiations for particular trade agreements.
Given the sensitive nature of the topic, informants were identified in the analysis by actor type and sector only (e.g. health advocate). The Australian National University Human Research Ethics Committee approved the research (protocol number 2013/076).
Results
Drawing on the insights from interviews with key informants in trade policy and health in Australia, we identify several categories of factors that are known to be related to the governance of policy issues(Reference Cairney19–Reference Clapp and Fuchs21). Specifically, we reveal several formal and informal mechanisms and structures that different policy actors use inside and outside the trade negotiations as they attempt to influence trade agreements. We also identify that different policy actors have different forms of power, which means they use different strategies through the various mechanisms and structures. Table 2 provides an overview of the key mechanisms and structures within the governance of trade agreements that matter, according to Australian trade policy actors, when trying to ensure policy coherence for nutrition purposes.
Inside the negotiations
The first main finding from the interviews was the identification of a number of formal and informal structures located within the trade agreement consultation and negotiation processes that can be used to help improve policy coherence. The various policy actors (health organizations, industry, academics and government officials) used these structures and processes differently and were more or less supportive of their ability to influence trade agreement decision-making processes.
Formal structures
Within government, interdepartmental committees and consultations may be set up when a trade agreement is being negotiated. For actors within the different government departments, these are considered the main formal mechanism via which health issues related to a trade agreement are considered:
‘I think in terms of consulting with other agencies, that’s always existed. We don’t make treaties in a bubble. We are the foremost foreign affairs agency and trade policy agency, but we need the expertise of other relevant agencies to inform those negotiations.’ (Federal public servant)
This mechanism was seen as an important and useful one in Australia, where trade and health government officials discussed the tobacco carve out in the Trans Pacific Partnership Agreement. Generally, however, according to participants, health officials were not considered particularly influential, nor were they invited to provide input in relation to trade and food issues. Food-related trade matters were reportedly led, generally, via the Department of Agriculture, which tends to place an emphasis on export promotion and food safety rather than nutrition.
The formal engagement mechanisms between government and non-government stakeholders including businesses and NGO include invited submissions and consultation rounds related to a specific trade agreement. While recognized as important for setting the trade agreement agenda, not all stakeholders have the same influence or confidence in these processes. Informants from business (agricultural, retail and general business sectors) suggested that it was important to be inside formal structures early on, noting that ‘if you fundamentally want to address the direction of trade policy and the outcome of an agreement then once the negotiation is underway it’s almost too late’.
Likewise, business actors noted varying capacity among organizations to usefully inform these processes, for example: ‘we want considered opinions or considered positions going into government, not just wish lists, which is what a lot of organizations take, as far as I understand it, and they don’t understand the process’.
NGO were less positive about the authenticity and capacity of government officials to engage with stakeholders, noting that the ‘instincts of trade negotiators are still not naturally leaning towards consulting with the community; you have to kind of find out what’s going on and then ask for consultation’.
One NGO representative reported on the changing process for consultation during the Trans Pacific Partnership negotiations:
‘I just don’t think that DFAT [Department of Foreign Affairs and Trade] has the same culture [as other departments, with respect to consultation]. I’ve never seen any signs of it. If anything I think there’s a resistance to it and an example I would give of that was as soon as there was a change of government in 2013 to the extent that DFAT was holding consultations with stakeholders around the TPP [Trans Pacific Partnership], or discussions at least, they stopped, and it was only when we went to the Trade Minister and this came up in conversation that they seemed surprised … later they started again but it just gave me the sense that it’s not something DFAT enjoys doing or does because it sees inherent benefits in doing it.’
Another NGO participant noted that:
‘Dealing with the department is like head-butting a brick wall. We try and try but in the end it comes down to the ludicrous “complications”. This idea of having to develop very, very specific questions around textual provisions we have had no way of seeing is absurd.’
Informal mechanisms
The rules of the game that apply to interdepartmental committees and consultations do not apply in the context of informal mechanisms, where business, NGO and health advocates use a variety of strategies to push their interests in trade treaty negotiations.
According to one informant, for example, it is not uncommon for industry representatives to demand from the deal well above what they consider to be a good outcome:
‘Say we want 100 000 tonnes of sugar into the US, say, that will make us happy; that will be a good outcome … [to the Australian negotiators] we say “we want 700 000 tonnes of sugar into the US; that would be good for us”.’ (Industry representative)
In turn, they tell other state actors they want even more extreme concessions so that the state requests seem more reasonable:
‘We meet with other government officials … and say to them “you know how the Australian government officials told you we want 700 000 tonnes? Actually we want 1000 tonnes …”. They then have the resources to stand outside the negotiating doors, getting updates from government negotiators and reminding them to “get in there and make sure you get 700 000 tonnes of sugar into the US, otherwise we’re going to raise a stink back in Australia and say this is a crap deal”.’
NGO and health advocates also reported using informal strategies to influence trade negotiations. These included writing to the trade negotiators to request consultations and attending trade negotiating rounds and ministerial meetings to speak to negotiators in the side-lines. There were mixed views on whether this was more revealing than formal consultations; ‘they will tell you the topics that are being discussed generally but you have to really ask a lot of questions to get any detail at all’. Another reported:
‘They were very open in so far as they could be. They certainly were receptive to listen to what we had to say … I have a criticism of the parameters in which they worked, which is the secrecy provisions.’ (NGO representative)
However, resourcing was seen as a barrier for NGO (and less wealthy countries) to attend different negotiating rounds and manage the complexity of trade negotiations, and so their ability to influence trade agreements via this mechanism was considered weak relative to better-resourced stakeholders:
‘You know, those countries [low-income countries], civil society really struggles there to exist or to even be active on local health issues, let alone trade agreements, so there is a real resourcing problem.’ (NGO representative)
Outside the negotiations
The interviews identified mechanisms external to the negotiations that were also considered as being important ways of influencing the content of trade agreements. As with mechanisms inside the negotiations, these outside mechanisms were both formal and informal in nature as described below.
Formal structures
Several government officials identified that the lack of either a national policy on nutrition or a binding international framework (akin to the Framework Convention for Tobacco Control (FCTC)) meant that they had no mandate to push for the consideration of nutrition in trade agreements without them.
Respondents noted that the FCTC is an important international legally binding treaty, which, by its existence, gives impetus to the consideration of tobacco-related health concerns when trade agreements are being developed. While such a treaty does not exist for nutrition per se, several respondents noted that in theory Codex Alimentarius offers the potential to function in a similar manner. Codex is the world’s foremost food-standard setting body. However, country delegations to Codex are often stacked with industry representatives and with little civil society input(Reference Berman22). It is noteworthy that a respondent from the Australian industry acknowledged the ability of industry to influence government officials during Codex meetings:
‘I’ve gone along as an official and sat beside them and whispered in their ears. You know, that’s worked quite well, and the other countries do it as well, you know, they’ve got their industry in there.’ (Industry representative)
NGO indicated that they used a number of other formal mechanisms outside the negotiating process to attempt to influence trade negotiations and trade policy including making submissions to Parliamentary committees and independent government inquiries on trade policy, and by seeking to influence health policy makers to adopt nutrition and health legislation:
‘The Joint Parliamentary Standing Committee on Treaties … is an important committee because that’s an opportunity for us to review, where they call for public submissions and have public hearings, there’s an opportunity for all groups, industry and other groups, to make presentations to the committee and make our views known.’ (NGO representative)
NGO reported, however, that a lack of transparency in the formal negotiation process had an impact outside negotiations – in that Parliamentary committees could only see text once it had been signed by trade ministers and could only recommend whether or not the agreement should be ratified. Nevertheless, NGO saw these formal processes as ways to create public awareness and engage with politicians tasked with reviewing the agreements. Business representatives also noted the importance of the public voice concerning trade, suggesting there was a need for ‘improved public debate over particular topics’ and that ‘the negotiators then are informed by the public debate’.
Informal mechanisms
The power of industry in the governance of trade agreements is clear. Some industry representatives discussed lobbying Members of Parliament as an important informal mechanism for influencing negotiations. These actors insisted that they had regular and easy access to politicians:
‘You know, the Department of Foreign Affairs’ door is always open, the minister’s door is always open. They’re always happy to receive things. They may not want to hear it but they’re happy to receive it.’ (Industry representative)
These actors were of the belief that if you have a strong public profile on trade issues and technical knowledge you will be listened to, and were perhaps unaware that their economic power may afford them preferential access and influence. One industry informant also noted the value of hiring former government representatives, often referred to as the ‘revolving door’ in the literature, ‘we understand the process much better because we’ve now got somebody who understands the process’.
NGO reported using several informal strategies and mechanisms outside the negotiation process to counter power imbalances in the inside mechanisms and the perceived lack of transparency. First, NGO established and acted collectively with both domestic and international networks involving consumer and health organizations. Domestic networks were formed between health, environment and other social organizations to share information and advice on how trade could impact various issues including food security and sovereignty, food safety and food labelling:
‘We have a series of loose coalitions, just people who get together. One involves parliamentarians. Another is organizations like us – these ones [on trade and health] were relatively informal.’ (NGO representative)
International networks were created with consumer and health organizations in other countries party to trade negotiations, which NGO saw as useful to glean information, particularly when some countries shared more information than others:
‘We try and make contact with whatever equivalents there are in other countries. So with the TPP there are about nine countries in which there are active civil society groups on different issues like public health or other issues that are really about the social impacts of trade agreements, so we have formed a network. The Internet makes this a lot easier because we have email networks and we also are able to have telephone conferences and exchange information, but mostly through email.’ (NGO representative)
In addition to sharing information, NGO focused on shared media strategies to deliver the same messages:
‘When you’ve all got a lot of people saying the same thing at the same time then definitely that voice will be heard louder than if we’re all shouting different things.’
Some NGO reported that it was important to identify supportive journalists in order to influence public opinion:
‘There were a couple of outstanding journalists who continued the process and looked at it and looked – and sometimes they didn’t go the way we wanted but at least they were looking at it.’
Second, in the context of limited transparency of trade negotiations, all NGO respondents highlighted the importance of accessing and sharing leaked negotiating text (via sites like WikiLeaks) to develop some understanding of the potential issues for health and nutrition:
‘Without the leak there would have been no way to raise legitimate concerns. For a start, we wouldn’t have heard about it, but also we wouldn’t have had anything to tell the public.’ (NGO representative)
The leaks provided a way for NGO to push for formal consultations within the negotiations and to develop analyses to share with politicians and the public outside the negotiations. In contrast, business actors noted the immediacy of their access to negotiators:
‘We recognise it’s a government-to-government negotiation but we are outside the door. When they walk outside the door we say “how did you go? What are you up to? What’s the” – you know, and they give us as much information as they can without contravening their governance requirements.’ (Industry representative)
Third, NGO reported lobbying individual politicians through sharing briefing papers and holding meetings with Members of Parliament and relevant Ministers and Shadow Ministers from all political persuasions:
‘We talk to all elected politicians from all parties about what’s happening with trade agreements and send them regular briefing papers and have meetings with them … we got to Canberra at least twice a year to actually do a round of discussions with MPs and senators on these issues.’ (NGO representative)
However, NGO representatives commented that it was more difficult to get meetings with Trade Ministers from conservative political parties. For example, one informant reflected:
‘With the election of the conservative government [in 2013] we wrote immediately to the Minister and asked for a meeting and it took a long time to get a reply and then we had a meeting with his trade advisor and that’s the only meeting we’ve ever had.’
Issues of power
The different forms of power used by the different actors in navigating the above structures and processes in a way that enables socially oriented goals, such as nutrition, was alluded to in the accounts above. More specifically, these accounts demonstrate various levels of structural power (i.e. the power to shape and engage in rules and institutional arrangements) and instrumental power (i.e. the power to directly influence decision makers through, for example, participation in shared networks/coalitions and by lobbying).
Interviews with the various representatives also demonstrated the importance of ideational power, the power of ideas and frames deployed by actors in their various discourses. Such frames are embedded within deeper ‘policy paradigms’ – coherent sets of guiding principles and causal beliefs, both technical and ideological in content, that function as ‘road maps’ for experts, government official and interest groups(Reference Hall23). Industry representatives framed trade liberalization as being about enhancing the efficient allocation of resources and achieving economic growth through market access. Underlying this frame is the assumption that free trade improves the livelihood of all. These actors indicated that issues like the environment and public health do not belong on the trade policy agenda:
‘The thing that we get disturbed about is this entry of new issues into the trade debates, be it the environment, be it public health, be it other things. The more issues you put on the table the harder it is and the more that there’s opportunity for trade-offs, and possibly perverse trade-offs, so we don’t like it as a context.’ (Industry representative)
One industry informant believed that government should play only a minimal role in regulating free enterprise, while some indicated a lack of trust in government being at the helm of these negotiations:
‘In the beginning there was trade. Then came government and since then government’s been f*cking it up.’ (Industry representative)
Likewise, industry actors employed traditional ‘lifestyle’ frames, noting that public health should confine itself to the domain of educating people on a healthy diet rather than taxation:
‘From a public health point of view the best way to get a better nutritional health outcome … is you want food to be relatively inexpensive but you want people to make the choices about the foods … based on the education they have and what healthier eating is. If you try and influence it by other means, so if you try and influence by affordability … they tend to be regressive and they’ll affect the lower socio-economic groups more than the other groups.’ (Industry representative)
NGO identified this as a ‘neoliberal’ discourse and as a primary barrier to elevating nutrition objectives both in trade and domestic health policy making. As NGO informants noted:
‘What we’re talking about is a value-based food system that requires a fundamental re-ordering of priorities.’
‘The food system as it’s currently structured and government policy, including trade policy, is very much about the goal of boosting short-term and financial sector profit and capital accumulation.’
Underlying this frame is the belief that the current trade system is deeply unjust, that it reinforces the power of transnational capital and ‘Big Food’ to the detriment of those with social and environmental interests. In this view an alternative trading system emphasizing ‘fair’ over ‘free’ trade is needed. This requires a deeper structural change in the operating logic of the economy that establishes health, human rights and ecological integrity as key objectives.
Conclusions
Our identification of formal and informal structures and processes that different actors use both inside and outside trade negotiations as they attempt to influence trade agreements revealed several lessons for public health and nutrition advocates to improve policy coherence for nutrition goals. Given the significant structural and instrumental power asymmetries between economic and socially oriented actors, and the imbalances in the access that health and industry stakeholders have to the various structures and processes, it is important that health stakeholders press for reform of these and make use of a mixture of these avenues for health and nutrition advocacy. Similarly, the demonstration of how a strong economic discourse on trade can present barriers to coherence with other policy agendas, such as nutrition, points towards the need to reframe the role of trade agreements. Moving forward therefore towards nutrition-sensitive trade agreements requires policy makers, researchers and health advocates to use various strategies including: reframing the role of trade agreements to include health outcomes; reforming the process to allow greater access and voice to health arguments and stakeholders; establishing cross-government partners through accountable committees; and building circles of consensus and coalitions of sympathetic public-interest actors.
While the evidence presented is limited to Australia, economic globalization and interdependence between sectors and countries means that these findings are likely to resonate with experience in other places. For example, recent research on policy coherence in South Africa has highlighted a similar divide between access of industry to economic policy makers and access by public health actors(Reference Thow, Greenberg and Hara24).
Coherent action across sectors to prevent diet-related disease will not be achieved unless issues of trade and nutrition are resolved and synergies found. Twenty-first century trade agreements must seek to support priority global policy agendas such as the UN Decade of Action on Nutrition. The salience of these issues is heightened by the Sustainable Development Goals in which widespread commitments to further trade liberalization are positioned as key mechanisms via which to pursue the Sustainable Development Goals(25), emphasizing the importance of understanding increasingly complex modes of governance to promote policy coherence for sustainable development and nutrition.
Acknowledgements
Financial support: This research was supported by core funding from the Australian Research Council (ARC) Discovery Project, ‘Trade policy: Maximising benefits for nutrition, food security, human health, and the economy’ (grant number DP130101478). Additional in-kind support was provided via the National Health and Medical Research Council (NHMRC) Centre of Research Excellence on the Social Determinants of Health Equity: ‘Policy research on the social determinants of health equity’ (grant number APP1078046). The ARC and the NHMRC had no role in the design, analysis or writing of this article. Conflict of interest: None. Authorship: S.F., P.B., A.M.T. and D.B. contributed to the research design and execution; S.F., P.B., B.T. and A.S. contributed to data analysis; and all authors contributed to the writing of the article. Ethics of human subject participation: This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving research study participants were approved by The Australian National University Human Research Ethics Committee. Written informed consent was obtained from all participants.
